How many companies in cities across Orange County received FDA citations in February?

James “Jim” Sigg FDA\'s Deputy Commissioner for Operations and Chief Operating Officer | Official Website

By Central OC Times

Mar 1, 2024

There were three companies in cities associated with Orange County that received FDA citations as a result of three inspections conducted in the county in February, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 200% increase over the number of companies cited in the previous month.

The citations in the county include:

Procedures have not been adequately established to control product that does not conform to specified requirements.
Procedures for corrective and preventive action have not been adequately established.
Complaint files are not adequately maintained.

All of the companies cited were involved in either Devices, Drugs, or Food and Cosmetics sectors.

All of the companies cited should take voluntary actions to correct their managing operations.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Companies located within Orange County Cities and the citations they received in February

Company Name	Area of Business	Inspection Date	Issue Cited
BioDuro, LLC	Drugs	02/23/2024	Procedures not in writing, fully followed
BioDuro, LLC	Drugs	02/23/2024	Equipment Design, Size and Location
BioDuro, LLC	Drugs	02/23/2024	Absence of Written Procedures
BioDuro, LLC	Drugs	02/23/2024	Scientifically sound laboratory controls
BioDuro, LLC	Drugs	02/23/2024	Testing and release for distribution
BioDuro, LLC	Drugs	02/23/2024	Acceptance criteria for sampling & testing
BioDuro, LLC	Drugs	02/23/2024	Records reviewed annually
BioDuro, LLC	Drugs	02/23/2024	Investigations of discrepancies, failures
Biogennix, LLC	Devices	02/08/2024	Nonconforming product, Lack of or inadequate procedures
Biogennix, LLC	Devices	02/08/2024	Lack of or inadequate procedures
Biogennix, LLC	Devices	02/08/2024	Complaints
Flavorchem Corporation	Food and Cosmetics	02/07/2024	Plant operations - Precautions